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Molecular Alterations Associated With Resistance to Endocrine Therapy and Impacting Treatment With mTOR Inhibitor (SAFIR-TOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02444390
Recruitment Status : Active, not recruiting
First Posted : May 14, 2015
Last Update Posted : November 4, 2021
Fondation ARC
Information provided by (Responsible Party):

Brief Summary:
This is a prospective biomarker study to show that p4EBP1 staining predicts clinical benefit from treatment with everolimus in patients who are eligible for everolimus+exemestane treatment. This trial is not aimed at evaluating a drug activity. Everolimus and exemestane are prescribed within their approved indication as per usual practice and are not part of this trial.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Procedure: Biopsy Not Applicable

Detailed Description:
Estrogen hormone receptor-positive metastatic breast cancer who failed to non steroidal aromatases inhibitors in patients who are eligible for everolimus+exemestane treatment

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Identification of the Molecular Alterations Associated With Resistance to Endocrine Therapy and Impacting Treatment With mTOR Inhibitor of HR+ Metastatic Breast Cancer in Post-menopausal Women
Actual Study Start Date : May 19, 2015
Actual Primary Completion Date : October 2018
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Exemestane

Arm Intervention/treatment
Exemestane+everolimus are administered as per their approved indication
Procedure: Biopsy
biopsy of a metastasis

Primary Outcome Measures :
  1. the predictive value of p4EBP1 for an mTOR inhibitor efficacy [ Time Frame: from inclusion up to 6 months ]
    The primary endpoint of the trial is the predictive value of p4EBP1 for an mTOR inhibitor efficacy, measured by the association between expression level of the biomarker (high vs low expression with a cutoff value set at the median percentages of marked cells) and clinical benefit after 6 months of everolimus+exemestane treatment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

- Eligible for everolimus+exemestane treatment as required by the marketing authorisation conditions

  1. Women (or men) with histologically-proven Estrogen Receptor-positive (ER+) and/or Progesterone Receptor-positive (PR+) / Human Epidermal growth factor Receptor 2-negative (HER2-) metastatic breast adenocarcinoma or locally advanced disease who cannot be treated with surgery and/or radiation therapy
  2. Postmenopausal women
  3. Asymptomatic if visceral disease
  4. Second line hormonotherapy or more for metastatic or locally advanced disease after recurrence or progression following a non-steroidal aromatase inhibitor (in adjuvant or metastatic setting)

    - Eligible for the biopsy

  5. Progressive disease under endocrine therapy at the time of inclusion
  6. Treatment with everolimus and exemestane not yet started
  7. Patients with metastases that can be biopsied, except bone metastases
  8. Measurable or evaluable disease
  9. Age ≥18 years
  10. WHO Performance Status 0/1
  11. Provision of signed and dated, written informed consent prior to any protocol specific procedure, including biopsy
  12. Patient with social insurance coverage

Exclusion Criteria:

  1. Contraindications for everolimus+exemestane treatment
  2. Previous treatment with an anti-mTOR therapy
  3. More than 1 previous line of chemotherapy in metastatic setting
  4. Life expectancy <3 months
  5. Spinal cord compression and/or symptomatic or progressive brain metastases (unless asymptomatic or treated and stable off steroids for at least 30 days prior to start of study drug)
  6. Haematopoietic function or organ impairment as shown by the following criteria:

    • Polynuclear neutrophils <1.5 x 10⁹/L
    • Platelets <100 x 10⁹/L
    • Haemoglobin <90 g/L
    • Alanine aminotransferase (ALAT) / aspartate aminotransferase (ASAT) >2.5 x ULN in the absence of or >5 x upper limit of normal (ULN) in the presence of liver metastases
    • Bilirubin >1.5 x ULN
    • Creatinine clearance ≤50 mL/min (measured or calculated by Cockcroft and Gault formula)
    • Calcium and phosphate >ULN
  7. Abnormal coagulation or any other medical situation contraindicating biopsy
  8. Bone metastases when this is the only site of biopsiable disease
  9. Any condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol
  10. Individuals deprived of liberty or placed under the authority of a tutor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02444390

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Institut de Cancérologie de l'Ouest/Paul Papin
Angers, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre Léon Bérard
Lyon, France
Institut de Cancérologie de l'Ouest/Rene Gauducheau
Nantes, France
Centre Antoine Lacassagne
Nice, France
Institut Curie
Paris, France
Clinique Armoricaine de Radiologie
Saint-Brieuc, France
Centre Paul Strauss
Strasbourg, France
Institut Claudius Regaud
Toulouse, France
Institut de Cancerologie de Lorraine Alexis Vautrin
Vandoeuvre-les-nancy, France
Gustave Roussy
Villejuif, France
Sponsors and Collaborators
Fondation ARC
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Principal Investigator: Thomas Bachelot, MD Centre Léon Bérard, Lyon, France
  Study Documents (Full-Text)

Documents provided by UNICANCER:
Statistical Analysis Plan  [PDF] October 30, 2018

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Responsible Party: UNICANCER Identifier: NCT02444390    
Other Study ID Numbers: UC-0105/1403
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: November 4, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by UNICANCER:
Failed non steroidal aromatases inhibitors
Eligible for everolimus+exemestane
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases